Efficacy of Hypomethylating Agents vs. Intensive Chemotherapy in Acute Myeloid Leukemia Using 5hmC as a Blood-Based Minimal Residual Disease Marker

Launched by THE METHODIST HOSPITAL RESEARCH INSTITUTE · Jul 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to monitor and treat adults newly diagnosed with acute myeloid leukemia (AML), a type of blood cancer. Researchers are testing whether a blood test that looks for a specific marker called 5hmC can help doctors better understand how much cancer remains after initial treatment. The study compares two treatment approaches: a gentler therapy using hypomethylating agents (HMA) and a stronger, more intensive chemotherapy. The goal is to see which treatment works better when guided by this new blood test, by looking at how long patients stay in remission and how long they live without the cancer coming back.

Adults aged 18 and older with newly diagnosed AML may be eligible to join, as long as they expect to live at least six months and can follow the study’s treatment and visit schedule. Participants will have blood samples taken at different times to check for cancer cells using the 5hmC marker. This helps doctors make informed decisions about the next steps in treatment. The study will include about 112 people and is currently not yet recruiting. Women who can become pregnant and men will need to use reliable birth control during the study and for a short time afterward. This trial aims to improve how AML is treated by using a simple blood test to guide therapy choices and better track disease progress.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The patient (or legally acceptable representative if applicable) provides written informed consent for the trial. Spanish speaking patients will be included and translation services will be provided as needed.
• • 2. Male or female, 18 years of age or older, on the day of informed consent signing.
• • 3. Newly diagnosed de novo AML
• 5. Expected life expectancy of at least 6 months 6. Willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits and examinations. 7. Women with childbearing potential and men should practice at least one of the following methods of birth control throughout the study and for 6 for women and 3 months for men after the last dose of study therapy:
• • 1. Total abstinence from sexual intercourse (periodic abstinence not acceptable);
• • 2. Surgically sterile partner(s) including vasectomy, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy;
• • 3. Practicing 2 effective methods of contraception (at least 1 highly effective, method of contraception \[See Appendix 4\]). WOCBP should only be included after a confirmed negative serum pregnancy test.
• Exclusion Criteria:
• • 1. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of trial treatment administration.
• • 2. The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study
• • 3. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• • 4. Confirmed positive pregnancy test in WOCBP.